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Richmond Va-based INSMED, a US-based follow-on biologics manufacturer, posted a press release on its website entitled: “Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company” that reports on the results from a Phase I clinical trial that demonstrated that it lead product INS-19 was bioequivalent to Amgen’s Neupogen^(R) (recombinant G-CSF) in stimulating human white blood cell production. 

, Dr. Geoffrey Allan, President and CEO of Insmed said  "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. “ The company has requested a meeting with FDA to discuss the design of a Phase III human clinical trial for INS-19.

I am not sure why INSMED is so excited about its results. Sandoz essentially accomplished the same feat with Omnitrope, its biosimilar version of recombinant human growth hormone (HGH)and it took a law suit and a loophole in the approval process for growth hormones for FDA to allow it to be sold in the US. In my opinion, until legislation is passed that provides a clearly defined legal pathway for approval of follow-on biologics I suspect that INS-19 will suffer the same fate (or perhaps worse) than Omnitrope. Bioequivalence is only legal defined for and relevant for approval of small molecule NOT BIOLOGICS when seeking expedited approval for generic versions of branded products. That said, I want to tip my hat to INSMED for its willingness to take a lead role in the fight to get follow-on biologics approved in the US. Finally, there is nothing like an edgy press release and a few bloggers to bring an issue that is rapidly losing momentum back to the forefront.

Kudos to INSMED!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

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Each year Fortune publishes a list of the top 100 companies that it believes are the best to work for. A quick perusal of the 2008 list reveals that only two drug companies cracked the top 100 this year. Genentech was ranked number 3 (second place in 2007) and Astra Zeneca finished a distant 83rd. The only other big pharma company to ever make the list was Eli Lilly in 2006 which came in at number 52. I guess that in general, big pharma companies aren’t great places to work?

As Ed Silverman at Pharmalot points out, “Amgen wins the award for taking the biggest dive. The biotech ranked #39 in 2006 and #40 in 2007, but this year doesn’t rank at all.” I suspect that Amgen’s hasty exit from the list has a lot to with large job layoffs, a grossly over paid CEO, a flagging stock price and a weak pipeline. One company that I think ought to be on this year’s list is Massachusetts-based Genzyme which has a reputation for having outstanding employee development and retention programs. It made the list in 2006 (no. 51) and 2007 (no.43) but was conspicuously absent this year. Maybe things have changed at Genzyme?

Until next time

Good Luck and Good Job Hunting (try Genentech, houses are currently cheap in the Bay area)!!!!!!!!!!!

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In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). The remaining three are “knock off” versions of erythropoietin alpha–Binocrit (Sandoz), Epoetin alpha Hexal (Hexal) and Abseamed (Medice Arneimittel Putter).

There is no doubt, at this point, that Europe is leading the way in the biosimilar space. However, it is important to point out that a variety of biosimilars, developed by Indian generic manufacturers and others, are already being sold in less- regulated Asian markets (see Table 1). Unfortunately, political issues and the fierce struggle between innovator

Table 1. Biosimilar Manufacturers and Their Products

biotechnology companies and generic manufacturers have delayed development of legislation for regulatory approval of follow-on biologics (American lingo for biosimilars) in the US. Further, and perhaps more perplexing, the FDA has been reluctant to issue any guidance on the topic. However, rising drug costs and increasing expenditures on biologics (both by Medicare and private insurers) have left American lawmakers with no choice but to craft legislation for approval of follow-on biologics.

In the first half of 2007 alone, three different bills were proposed to craft a statutory pathway for the approval of follow-on biologics under the Biologic License Application (BLA). The first of these bills–The Access to Life-Saving Medicine Act– was introduced into Congress by Representative Henry Waxman (CA) and into Senate by Senator Chuck Schumer (NY) in February. The second bill–the Patent Protection and Innovative Biologic Medicine Act –was introduced in Congress in April by Representative Jay Inslee (WA). Neither bill made any progress. This is because the Access to Life-Saving Medicine Act was considered to be heavily pro-follow-on whereas the Patent Protection and Innovative Biologic Medicine Act was deemed to favor innovator companies and did not provide any financial incentives for follow-on manufacturers.

A compromise was reached by both Republican and Democrat Senators and the Biologics Price Protection and Innovation Act was approved by the Senate on June 27.  It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first follow-on biologic to be approved as interchangeable with the reference product.  I previously aired my views on the proposed legislation. For a more in depth analysis of the issues and the bills, please read this.

Recently, there was an important new regulatory development in the European biosimilar landscape. Sandoz’s EPO, Binocrit, received the same nonproprietary name (INN) as Amgen’s original erythropoietin alpha (Epogen in the US, Eprex in Europe).This was a big win for the biosimilar industry because the INN debate had been raging in the EU for the past several years. Innovator companies wanted biosimilars to have different INN than their products whereas biosimilar manufacturers were lobbying for identical INN designation. An identical INN designation allows for  interchangeability of medicines. The fact that EMEA granted Binocrit the same INN number as Eprex, means that the agency views the two products as biologically-equivalent and interchangeable. This paves the way for EU pharmacists to freely substitute Binocrit for the more expensive Eprex. Also, it sends a message to US lawmakers and FDA that the EU considers certain biosimilars as interchangeable with their innovator counterparts. As you may have guessed, the issue of interchangeability is being hotly debated and contested by advocates on both sides of the follow-on biologics fence.

The US is clearly dragging its feet in the follow-on biologics arena. The prime driver of this inertia is the imagined loss of revenue that many innovator companies fear will occur if the US ultimately divines a regulatory approval pathway for follow-on biologics. That said, with Europe and India leading the charge into Asia, it looks as though the US is going to loss a substantial amount of money (not to mention market share) anyway.

With regard to biosimilars in the US, it is no longer a question of “if” but “when.” That said, I think that the one seminal issue that needs to be addressed is what to call these things in the US?  In my opinion, the European moniker, biosimilar, is particularly apt and appropriate for this new class of medicines. Unfortunately, we Americans don’t like to play second fiddle to anybody, especially the Europeans. With this in mind, I have no doubt that they WILL NOT be called biosimilars in the US. Whatever they are called, don’t be surprised to find them your pharmacist’s shelves in the next couple f years!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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The first biosimilar version of granulocyte colony stimulating factor (G-CSF) received a positive opinion from EMEA last month.  The European commission is expected to grant marketing approval for the product in the EU. The product, developed by Israel-based Teva, a global generics manufacturer, will be sold under the brand name TevaGrastim. The company is seeking EU approval for TevaGrastim a as treatment of chemotherapy-induced neutropenia.  

Amgen’s Neupogen, the innovator product, yields annual revenues of approximately $300 million in the EU. Teva hopes to cash in on a piece of that action. It appears that biosimilars are alive, well and making money in Europe!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Until recently, Amgen dominated the biotechnology industry and was anointed the world's largest biotechnology company.  However, Amgen recently lost its number 1 ranking to Genentech.  Over the past year or so, Amgen, which is now ranked number 2,  has been acting a lot  like Avis,  the car rental company , which in the 1970s adopted the slogan  “Avis: We Try Harder” when it was number 2 to Hertz in the car rental rankings.  Like Avis, which never overtook Hertz to claim the number 1 spot,  Amgen’s efforts to regain its number 1 ranking are failing.

Today, market analysts noted that, for the first time, Gilead Sciences had overtaken Amgen as the world's second most highly-valued biotech company. Genentech still maintains its comfortable number 1 ranking with an extraordinary market capitalization of more than $83 billion. That said, it is still somewhat of a horse race between Gilead and Amgen for the number 2 spot– as of this morning, Amgen's market cap was approximately $43.5 billion whereas Gilead's was $45.5 billion. Amgen is still ranked highest when it comes to annual revenues: $14.8 billion in 2007 versus Genentech's $11.7 billion and Gilead's $4.2 billion.

Are rankings really that important? Maybe we should ask the Georgetown and Duke men’s basketball teams after this weekend’s NCAA second round tournament games! They might have some interesting insights to share.

Until Next Time….

Good Luck and Good Job Hunting (Stay out of A Thousand Oaks)

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According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.

The advisor panel voted 13-1 to keep Amgen's Aranesp and J&J's on the market for use with chemotherapy. The recommendation was very surprising because over the last year FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels. Many analysts expected further recommendations for restrictions. Although the advisory panel vote is non-binding, FDA usually follows the advice of its panels when making regulatory decisions. However, it is important to note that FDA has not followed the advice of several advisory panels in the recent past.

The positive advisory panel vote is good news for J& J and Amgen because billions of dollars in revenue are at risk for the cancer indication.  I bet that J & J and Amgen executives breathed a collective sigh of relief after hearing the news!  Maybe that loud noise I heard earlier today was the popping of champagne corks at J & J corporate headquarters in New Brunswick, NJ.  

To quote Mark Twain: “The rumors of my death have been greatly exaggerated” is particularly apt for Amgen and J &J after today’s decision.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!

The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.

The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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A federal judge ruled that Amgen Inc. must defend itself against charges that it misled investors about safety concerns with its flagship anemia drug, Aranesp.

A US district court judge dismissed charges against five of nine Amgen officers and directors but left plaintiffs 30 days to amend their complaint in order to include those defendants. The investors, led by Connecticut Retirement Plans and Trust Funds, assert that positive statements made by company officials regarding the safety of Amgen's two anemia drugs, Aranesp and Epogen, were knowingly at odds with clinical studies that had raised concerns.

The plaintiffs assert, according to court filings, that they unknowingly purchased artificially inflated shares, between April 2004 and May 2007. In one instance, during its fourth-quarter 2006 conference call, Amgen announced results of a clinical trial that tested Aranesp in 939 patients with anemia from cancer. The Food and Drug Administration, according to court filings, described the study as "demonstrat(ing) significantly shorter survival rate in cancer patients receiving (anemia drugs) as compared with those (sic) receiving transfusion support."

Describing the results of the study during the conference call, Roger Perlmutter, a defendant and executive vice president of research and development, said, "We did not see a statistically significant adverse affect of Aranesp on overall mortality in this patient population, and so we conclude that the risk/benefit ratio for Aranesp in these extremely ill patients with anemia secondary to malignancy is, at best, neutral and perhaps negative."

Sounds misleading to me! It is unfortunate that companies compromise their scientific integrity and corporate reputation simply to boost their stock price in the short term. I think companies are slowly learning that if they are dishonest or disingenuous with the American public that the public will soon lose confidence in them and their products. This, in turn, will lead to a decrease in sales and ironically a reduction in company stock price. As the old adage goes “Honesty is always the best policy!”

Until next time….

Good luck and Good Job Hunting!!!!!!!!!!!!

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Amgen announced yesterday that its osteoporosis drug, denosumab, was safe and outperformed Merck’s Fosamax to improve bone density in a small Phase III clinical trial that included almost 1,200 patients. Unlike Fosamax which is taken orally once a month, denosumab (a fully humanized monoclonal antibody) only needs to be injected twice a year. As mentioned in a previous post, Fosamax will be losing patent protection and Merck recently announced that it will sell an authorized generic version of the drug. Fosamax and its generic equivalent represent the stiffest competition for denosumab if it receives regulatory approval.

Despite being the largest biotechnology company in the world, Amgen has struggled for the past year due to declining sales from its EPO franchise. Amgen’s pipeline is thin and company executives have bet the future on denosumab becoming a top seller. That said, the key measure for any osteoporosis drug is whether it can reduce or prevent bone fractures. Results from a pivotal Phase III clinical trial with over 8,000 patients comparing denosumab to placebo in fracture prevention are expected later in 2008.

I bet  a lot of employees in a Thousand Oaks have their fingers crossed!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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Still reeling from lawsuits filed last week by ex-sales reps’ alleging improper marking of Enbrel to treat patients with psoriasis, Amgen was subpoenaed on Monday by New Jersey's attorney general regarding allegations that the company promoted Enbrel for unapproved uses.

In the subpoena served Monday, Attorney General Anne Milgram is seeking "a comprehensive array of documents and information" concerning the marketing and sale of Enbrel from July 2002 to the present.

The subpoena calls for Amgen to deliver the required materials by Feb. 4.

Although doctors are free to prescribe medicines as they see fit, drug companies are only allowed to promote their products for uses that have been approved by the U.S. Food and Drug Administration and appear on product labels.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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As many of you know, the pharmaceutical industry has been trending downward for the past year or so. Weak pipelines, uncontrolled corporate expansion and soaring drug prices have been offered to explain the recent down turn. However, the real back story to the downturn is the loss of  future revenues that is expected to occur starting in 2010 when many current blockbuster pharmaceutical products, e.g., Lipitor (Pfizer), Plavix (Sanofi Aventis), Avandia (GlaxoSmithKline), Zyprexa (Lilly), and others lose patent protection.

The loss of patent protection of branded blockbuster products is almost always accompanied by the development and subsequent, regulatory approval of lower cost, generic versions of the drugs. The Hatch Waxman Act permits generic manufacturers to begin to develop generic versions of branded products five years prior to patent expiry. This allows generic manufacturers to develop and gain regulatory approval of their products well in advance of a patent expiry date. Further, generic manufacturers usually launch their products (and flood the market) with generic versions of a branded product on the same day that its patent lapses. To induce and hasten generic development, Hatch Waxman grants market exclusivity for 180-days (6 month) to the first company that gains US regulatory approval for a generic version of a branded product that has lost patent protection.

Revenue generation and a company’s market share of branded drug products generally fall precipitously following introduction of less costly, generic versions of the drugs. From a financial standpoint, this is not surprising—why would anybody chose to pay more for a branded product when there is a cheaper and therapeutically efficacious generic alternative available?  In the past, most pharmaceutical companies chose to neglect (and ultimately abandon) blockbuster products after generic versions were introduced.  Many companies chose this strategy because, in the past, there was always another blockbuster in the pipeline that would replace the lost revenues caused by generic competition.

Unfortunately, as we all know, the days of the billon-dollar-a year blockbuster drug are long gone! This realization has caused many pharmaceutical companies to rethink their business strategies when a blockbuster drugs lose patent expiry. Many pharmaceutical companies are experimenting with a relatively new kind of product called an authorized generic–a copycat version of a company’s branded drug that is sold through a licensing agreement between the innovator company and a generic-drug manufacturer. This type of arrangement allows the innovator company to hold on to a larger share of a revenue stream from the drug once it loses patent protection and it falls prey to generic manufacturers.

Authorized generics have always made sense to me–who knows how to manufacture, market and distribute a drug better than the company that originally created it? Further, why would a company choose to give up on a revenue stream simply because a product can no longer generate billions each year due to generic encroachment– wouldn’t hundreds or even tens of millions suffice? Much to my surprise, late last week, Merck & Co announced that it had inked a deal for an authorized generic form of its blockbuster osteoporosis drug  Fosamax after the US patent expires on February 6. Merck did not disclose the terms of the deal or the identity of it generic manufacturing partner.

Industry analysts have suggested that cheaper generics will not only batter sales of Merck’s Fosomax but could also hurt rival Actonel (Proctor & Gamble Co/Sanofi-Aventis) and Boniva (Roche/GalxoSmithKline). Generic manufacturers.  Barr Laboratories and TEVA are expected to launch their own generic versions on February 6 and share the 180-day market exclusivity for their respective products.

Merck, once a champion of the old pharma blockbuster model, is slowing emerging as an industry innovator. The company’s recent decision to authorize a generic version of one of its former blockbuster drugs may be a harbinger of things to come in the pharmaceutical industry. That said, I don’t understand why big biotechnology companies like Amgen, Biogen/IDEC and Genentech are unwilling to consider the authorized generic model to stave off generic competition for blockbuster biotechnology products like EPO, Avonex and Rituxan. Whether these companies like it or not, I believe that biogenerics aka follow-on biologics will be a reality in the US in the next five years. Maybe Amgen can bolster is rapidly falling stock price by inking an authorized generic deal for EPO—rather than spending hundreds of millions on patent litigation—“whadda ya think?”

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

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It goes without saying that Amgen has had a run of bad luck over the past six months. But, just when you thought things couldn’t get much worse, two former Amgen sales representatives are suing the company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of its blockbuster drug Enbrel.

The ex-employees are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece. One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after he received a negative performance review.

A lawyer representing the ex- reps alleges the marketing scheme to increase sales of the drug started in 2005 or sooner, after new drugs competing with Enbrel came on the market. "Amgen stepped up their marketing practices to get all these people who were not indicated for Enbrel" to start taking the drug, she said.

Enbrel which is approved to treat rheumatoid arthritis and moderate to severe cases of psoriasis generated $3.0 billion in sale for Amgen last year. Enbrel treatment can cost as much as $20,000-$50,000 per patient per year depending upon disease severity. 

Stay tuned for the next installment of the ongoing Amgen saga!

Until next time….

Good Luck and Good Job Hunting (not in A Thousand Oaks)!!!

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Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

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As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the go-ahead to Hospira and Stada to sell their copycat version of Johnson & Johnson's anemia drug Procrit.

The European Commission approved Retacrit (epoetin zeta), a biosimilar version of erythropoietin (EPO), to treat anemia associated with chronic renal failure and chemotherapy. EMEA regulators determined that the drug was comparable in efficacy and safety to Procrit.

The EPO market is a large one and more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, Procrit (JNJ; US), Eprex (JNJ; Europe) and Epogen (Amgen; US). Worldwide annual sales of EPO drugs are estimated at more than $7 billion, $600 million of which comes from Europe.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the first go-ahead in Europe to develop its version of epoetin alfa. Sales of Retracrit will begin in Germany in early 2008.

When are American pharmaceutical and biotechnology executives going to wake up and realize that they will lose millions in revenue to biosimilar competition?  I think the old adage; “If you can’t beat ‘em, join ‘em” is apt when talking about the biogenerics industry.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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I hate to be the bearer of bad news (don’t kill the messenger) but 2007 has been rife with corporate downsizing and job layoffs. According to a post at Fierce Biotech, jobs cuts were primarily driven by “Concerns about patent expirations, falling sales due to drug safety concerns, redundancy from acquisitions and a general need to streamline operations”. The companies that have “laid-off” the most workers are:  

1. Pfizer-10,000 
2. Astra Zeneca-7,600 
3. Bayer-6,100 
4. Johnson & Johnson
5. 5,000 Amgen-2,600

Companies that did not make the list but have quietly been laying off workers or freezing jobs include GlaxoSmithKline, Merck, Eli Lilly and Bristol-Myers Squibb.

It is not a good time to be looking for a job in the pharma or biotech industries. That said, there is always hope and let’s “hope” that 2008 is a better year for both industries.

Until next time….

Good Luck (you will need it) and Good Job Hunting!

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Swiss pharmaceuticals producer Roche Holding AG said Thursday it has received approval from the U.S. health authorities for its anemia drug Mircera, but is still awaiting resolution of a patent case before launching the drug in the United States.

Mircera, which has been approved by the U.S. Food and Drug Administration for patients with anemia caused by kidney failure, is the subject of a legal tussle between Roche and rival Amgen Inc.

The new EPO-like drug is already sold in Austria, Sweden, Germany, Britain and Norway, Roche said.

Amgen will fight Roche to the end on this one. But, I think Roche will prevail. Let’s hope so!!!!!!!

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A sharp drop in sales of its blockbuster diabetes medication Avandia has forced GlaxoSmithKline (GSK) to embark on a major cost cutting campaign that includes job cuts. It is not clear where the cuts will take place or how many jobs will be lost. The company said it would close some of its manufacturing plants, including a plant in Puerto Rico which employs around 900 workers and has been a target of regulatory scrutiny because of ongoing quality control issues.

Although this is the first official public announcement of layoffs at GSK, my inside sources tell me that several hundred employees have already lost their jobs at GSK’s Collegeville, PA facility.

GSK’s announcement coupled with a sharp drop in Amgen’s third quarter profits and Lilly’s problems with clinical development of prasugrel (its highly anticipated anti-clotting drug) indicate that the road will be rather bumpy for the biopharmaceutical sector in the near future.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!

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First, there was the torcetrapib catastrophe and now the Exubera debacle. Pfizer announced late yesterday that it would stop selling Exubera, the first approved inhaled insulin product, less than two years after its approval. Despite heavy promotion by Pfizer, Exubera sales were tiny, with prescriptions amounting to less than 1% of the multi-billion dollar insulin market.

Once heralded as a potential blockbuster drug by industry analysts, Exubera was plagued with questions about its safety, efficacy, convenience and cost. The bottom line is that it worked no better than injected insulin and, results from clinical trials showed that Exubera could decrease patients’ breathing ability. This coupled with the appearance of the delivery device, which resembled a bong (not that there is anything wrong with that), contributed to the inability of Exubera to gain acceptance among patients and physicians.

Exubera was originally developed by Nektar, a small publicly traded California-based biotechnology company that specializes in inhalation technology and protein delivery systems that include PEGylation. Pfizer bought the marketing rights from Nektar and assumed responsibility for clinical development of Exubera.

Nobody knows how much Pfizer spent on developing and promoting Exubera, but the company took a $2.8 million charge yesterday to cover costs associated with the drug–making it one of the most expensive failures in the history of the pharmaceutical industry.

Despite its status as the world’s largest pharmaceutical company, things are not going well for Pfizer. The company has already consolidated operations and laid off thousands of workers a result of the torcetrapib mess. Further, the ripple effect that the Exubera debacle may have on Nektar and other companies like Eli Lilly that are developing similar inhalable insulin products is unknown at present. 

I do not think that the pharmaceutical and biotechnology industries can withstand much more bad news. Pfizer’s  ongoing bad news, coupled with the GlaxoSmithKline’s Avandia mess and Amgen’s epoetin woes suggest that it may be a good time to load up  your portfolio with already “cheap” pharmaceutical and biotechnology stocks—there is only one way for these stocks to go—and that is up!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!

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This should not come as a big surprise (especially to the Amgen employees who already know that they will be losing their jobs) but Amgen announced today  that it will be cutting about 450 workers in its West Greenwich, Rhode Island biomanufacturing facility and laying off about 675 workers at its Thousand Oaks, California, headquarters. On Aug. 15, 2007, Amgen, which is the world's largest biotechnology company, announced plans to pare its staff by 12% to 14%, or roughly 2,220 to 2,600 workers, as part of a major restructuring plan.

Although somewhat troubling, this is the first time in 25 years that Amgen is restructuring and has been forced to downsize. Nevertheless, looking on the bright side for Amgen alumni, being formerly employed by the world's largest and most recognized biotechnology company is a not a bad thing when looking for a new job! 

Until next time….

Good Luck and Good Job Hunting……….

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The New York Times reported today that an FDA advisory committee voted on Monday against imposing a new restriction on the use of EPO-like drugs to treat dialysis patients with kidney disease, offering a rare reprieve to Amgen, the manufacturer of the drugs.

The panel voted 14-to-5 against an F.D.A. proposal to set a fairly specific upper range on the drugs’ use. Several studies have linked overuse of the drugs to cardiovascular problems and deaths and, when used to treat cancer patients, to a worsening of tumors.

Nevertheless, although yesterday’s vote made it less likely that there would be drastic restrictions on the use of the drugs in kidney patients, the levels of use are unlikely to return to those common before the safety concerns took hold. Even while rejecting the proposed ceiling, most panel members recommended a treatment target lower than what some dialysis clinics and kidney specialists previously used.

Further, the F.D.A. said it was proposing to remove assertions on drug labels that assert that use of these drugs improved the quality of life for patients, saying the data to support such claims was inadequate. In March, the F.D.A. changed the labels for EPO to say that these drugs should be used as sparingly as necessary to avoid blood transfusions and that hemoglobin levels should not exceed 12 grams a deciliter.

Yesterday’s panel was far easier on Amgen than one in May that considered the safety of the drugs for use by cancer patients. After that meeting, Medicare sharply reduced its reimbursement for EPO drugs used in cancer treatment. This decision caused Amgen’s stock price to plummet to its lowest levels in almost a decade.

Despite this small victory, it is unlikely that the decision will affect the previously announced layoffs scheduled to take place in the very near future at Amgen.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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I posted a piece several months ago that predicted that Amgen may be in for a rocky ride as a result of slowing revenue growth (due to increased regulatory scrutiny of its EPO franchise) and a relatively weak drug development pipeline. Not surprisingly, the Wall Street Journal reported on Thursday that there are signs that employee layoffs are likely in the near future (I am sure that this is a not a surprise for current Amgen employees). In documents filed with the SEC on Thursday, corporate language appeared that included phrases like “improve our cost structure,” “seek greater efficiencies” — corporate speak that layoffs are imminent.

Industry experts estimate that layoffs of up to 15% of Amgen’s workforce may take place. In support of this, last week, CEO Kevin Sharer sent a message to employees through the company’s voicemail system, saying changes could be in the offing.

I think it is time for Amgen employees to remove the dust from their resumes!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!

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